© Springer International Publishing Switzerland 2015 A. Chakrabarti, A. Surolia (eds.), Biochemical Roles of Eukaryotic Cell Surface Macromolecules, Advances in Experimental Medicine and Biology 842, DOI 10.1007/978-3-319-11280-0_21 Chapter 21 Regulations of Glycolipid: XI. Glycosyltransferase (GSL: GLTs) Genes Involved in SA-LeX and Related GSLs Biosynthesis in Carcinoma Cells by Biosimilar Ap...

Theauthors suggested that biosimilar qualitymight be inconsistent over time and suggested that track-and-trace capabilities might encourage consistent quality. Product quality is tightly regulatedby theFDA, both for referencebiologics and biosimilars. Each batch of every biologic must meet predetermined release specificationsbefore it canbeused to treat patients. These tight regulatory requirem...

Immune reconstitution inflammatory syndrome can present as a paradoxical reaction after initiation of antiretroviral treatment in patients with severe immunosuppression and underlying infections. Immune reconstitution inflammatory syndrome has often been associated with mycobacteria, and the clinical response to traditional treatment with corticosteroids is not always satisfactory. Consequently...

OBJECTIVES To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS). METHODS This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered in...

PURPOSE Biosimilars are a cost-effective alternative to biologics that could improve patients' access to expensive biological medicines. Currently, there are little data on doctors' perceptions of biosimilars and in what situations they are comfortable prescribing biosimilars. In this study, we investigated medical specialists' perceptions of biosimilars and the factors associated with the acce...

OBJECTIVES Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available produ...

Background Following the functional and physicochemical characterization of a proposed biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar safety and efficacy to the reference product in a sensitive patient population. Patients and methods LA-EP2006 is a proposed biosimilar that has been developed for pegfilgrastim, a long-acting form of granulocyte...

OBJECTIVES This study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars. METHODS Data were taken from the Adelphi Real World Biosimilars Programme, a real-world, cross-sectional study undertaken in 2015-2016 with German gastroenterologists and patients w...